Olumiant

RSS

baricitinib

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Olumiant. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Olumiant.

For practical information about using Olumiant, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 01/03/2018

Authorisation details

Product details
Name
Olumiant
Agency product number
EMEA/H/C/004085
Active substance
baricitinib
International non-proprietary name (INN) or common name
baricitinib
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA37
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
13/02/2017
Contact address
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

25/01/2018 Olumiant - EMEA/H/C/004085 - II/0003

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

IMMUNOSUPPRESSANTS

Therapeutic indication

Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs. Olumiant may be used as monotherapy or in combination with methotrexate.

Assessment history

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